Palbociclib + Chemotherapy for Childhood Leukemia and Lymphoma
What You Need to Know Before You Apply
What is the purpose of this trial?
AINV18P1 is a Phase 1 study where palbociclib will be administrated in combination with a standard re-induction platform in pediatric relapsed Acute Lymphoblastic Leukemia (ALL) and lymphoblastic lymphoma (LL). LL patients are included because the patient population is rare and these patients are most commonly treated with ALL regimens. The proposed palbociclib starting dose for this study will be 50 mg/m\^2/day for 21 days.
Who Is on the Research Team?
Elizabeth Raetz, MD
Principal Investigator
Children's Oncology Group
Are You a Good Fit for This Trial?
This trial is for children with relapsed Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Lymphoma (LL). They should have a certain level of bone marrow blasts, measurable disease, and be in good enough health to participate. Patients must not have been treated with palbociclib before and should meet specific heart, kidney, and liver function requirements.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Palbociclib in combination with chemotherapy for one cycle, 32 days
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term follow-up
Participants are monitored for adverse events and response to treatment
What Are the Treatments Tested in This Trial?
Interventions
- Palbociclib
Find a Clinic Near You
Who Is Running the Clinical Trial?
Children's Oncology Group
Lead Sponsor